The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: HD-Idarubicin/Etoposide Intensified Conditioning Regimen Allo-HSCT for Adult ALL
Official Title: An Open-label,Multi-center,Prospective Study of Idarubicin and Etoposide Intensified Conditioning Regimen Allogeneic Hematopoietic Stem Cell Transplantation for Adult Acute Lymphoblastic Leukemia
Study ID: NCT01873807
Brief Summary: Intensified conditioning regimen allo-HSCT is based on a hypothesis of that intensifying condition with less-used drugs could overcome resistance,reduce tumor burden, and most importantly, spare enough time for slow-growing GVL effect following immune reconstitution to finally get rid of MRD and control the disease. Our previous trial of HDE-ALL-2011 (NCT01457040) have confirmed the role of intensified conditioning allo-HSCT in adult ALL, resulting in significantly improved OS and EFS in comparison with previous standard TBI/CY2 conditioning regimen(data not yet published). But at the same time, FA-TBI/CY2-VP16 conditioning regimen was associated with high transplantation-related mortality (TRM), which might be attributed to excessive suppression on both bone marrow and immune. TT-ALL-HIE-2013, substituting FA with idarubicin, is aimed at maintaining anti-tumor effect with less cross-resistance and immune suppression and reducing TRM.
Detailed Description: It's well-known that the long-term outcome of adult acute lymphoblastic leukemia (ALL) lags far behind that of pediatric ALL,associated with different molecular cytogenetics make-up and treatment strategies. In search of an optimal regimen for pediatric ALL, comprehensive series of clinical trials of intensive chemotherapies have been conducted and lead to 80%-90% long-term survival. At the same time, pediatric-inspired chemotherapy protocol aslo yielded a charming result of 50-60% 3-year EFS in adolescent and young adult. In comparison with the leading role of intensive chemotherapy in pediatric ALL, allogeneic hematopoietic stem cell transplantation (allo-HSCT) plays an important role in treatment strategy of adult ALL. According to the state-of-art understanding of ALL, total therapy of ALL should consist of molecular-cytogenetics classification at diagnosis, minimal residual disease (MRD) monitoring and redefining risk classification during treatment, pediatric-inspired chemotherapy with high-dose Methotrexate/L-asparaginase during consolidation therapy,furthermore,risk/MRD-adapted allo-HSCT for high-risk and refractory/relapsed ALL.In pre-pediatric-inspired protocol era, allo-HSCT still represents the major role for improving the outcome of adult ALL, especially for high-risk and refractory/relapsed ALL. It's established that graft-versus-leukemia (GVL) effect was weak in ALL and patient shows poor response for donor-lymphocyte infusion (DLI). Intensified conditioning regimen allo-HSCT is based on a hypothesis of that intensifying condition with less-used drugs could overcome resistance,reduce tumor burden, and most importantly, spare enough time for slow-growing GVL effect following immune reconstitution to finally get rid of MRD and control the disease. Our previous trial of HDE-ALL-2011 (NCT01457040) have confirmed the role of intensified conditioning allo-HSCT in adult ALL, resulting in significantly improved OS and EFS in comparison with previous standard TBI/CY2 conditioning regimen(data not yet published). But at the same time, FA-TBI/CY2-VP16 conditioning regimen was associated with high transplantation-related mortality (TRM), which might be attributed to excessive suppression on both bone marrow and immune. TT-ALL-HIE-2013, substituting FA with idarubicin, is aimed at maintaining anti-tumor effect with less cross-resistance and immune suppression and reducing TRM.
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Department of Hematology, Union Hospital of Fujian Medical University, Fuzhou, Fujian, China
Guangzhou General Hospital of Guangzhou Military Command, Guangzhou, Guangdong, China
Guangdong General Hospital, Guangzhou, Guangdong, China
Guangdong No.2 Provincial People's Hospital, Guangzhou, Guangdong, China
Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China
Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China
Department of Hematology, 1st Guangzhou People Hospital, Guangzhou, Guangdong, China
Oncology-Hematology Center, 1st Affiliated Hospital, Guangzhou Medical Collgege, Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China
Zhongshan People Hospital,Guangdong, Zhongshan, Guangdong, China
Department of Hematology, 1st Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
Department of Hematology, Union Hospital, Huazhong Science and Technology, Wuhan, Hubei, China
Department of Hematology, Tongji Hospital, Huazhong Science and Technology, Wuhan, Hubei, China
Name: Qifa Liu, MD
Affiliation: Department of Hematologym, Nanfang Hospital, Southern Medical University, China
Role: PRINCIPAL_INVESTIGATOR